A Study to Assess Safety and Efficacy of ASP015K in Participants With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to Methotrexate (MTX)
A Randomized, Double-Blind, Placebo-Controlled Confirmatory Study of the Safety and Efficacy of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response or Intolerance to MTX
2 other identifiers
interventional
385
3 countries
43
Brief Summary
The purpose of this study is to verify the superiority of ASP015K in combination with MTX or with other disease-modifying antirheumatic drugs (DMARDs) over placebo in terms of efficacy in participants with rheumatoid arthritis (RA) who had an inadequate response or intolerance to MTX, as measured by the American College of Rheumatology (ACR) 20 response rate at Week 24. This study will also evaluate the pharmacokinetics and safety of ASP015K as well as efficacy and safety of long-term treatment with ASP015K (52 weeks).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2018
Typical duration for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2018
CompletedFirst Posted
Study publicly available on registry
September 6, 2018
CompletedStudy Start
First participant enrolled
September 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 2, 2021
CompletedOctober 21, 2024
October 1, 2024
2.5 years
August 26, 2018
October 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
American College of Rheumatology (ACR)20 response rate at Week 24
The ACR20 response requires that all criteria from (1) to (3) be met compared with Week 0 (baseline); (1), Tender Joint Count (TJC) \>= 20% reduction; (2), Swollen Joint Count (SJC) \>= 20% reduction;(3) \>= 20% improvement in three or more of the following five parameters - \[1\] subject's assessment of pain, \[2\] Subject's Global Assessment of Arthritis (SGA), \[3\] Physician's Global Assessment of Arthritis (PGA), \[4\] health assessment questionnaire-disability index (HAQ-DI), \[5\] acute phase reactant (C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR)).
At Week 24
Secondary Outcomes (33)
ACR20 response rate
Up to Week 52
ACR50 response rate
Up to Week 52
ACR70 response rate
Up to Week 52
Change from baseline in disease activity score (DAS) 28-C-reactive protein (CRP) scores
From baseline (Week 0) to Week 52
Change from baseline in DAS28- erythrocyte sedimentation rate (ESR) scores
From baseline (Week 0) to Week 52
- +28 more secondary outcomes
Study Arms (3)
ASP015K 100 mg
EXPERIMENTALParticipants will receive 100 milligrams (mg) of ASP015K once daily after breakfast for 52 weeks.
ASP015K 150 mg
EXPERIMENTALParticipants will receive 150 mg of ASP015K once daily after breakfast for 52 weeks.
Placebo/ASP015K
PLACEBO COMPARATORParticipants will receive placebo for 24 weeks, then either 100 mg or 150 mg of ASP015K for 28 weeks as determined randomly at Week 0 in advance.
Interventions
As necessary concomitant medications, DMARDs listed below will be administered orally unless specified. For subjects who are inadequate responders to methotrexate (MTX): MTX. For subjects who are intolerant of MTX: either of DMARDs listed; hydroxychloroquine, salazosulfapyridine, gold (injection or oral), D-penicillamine, lobenzarit, actarit, bucillamine and iguratimod.
Eligibility Criteria
You may qualify if:
- Subject is a man or woman and considered to be an adult, according to the local legal definition, at the time of informed consent.
- Subject has RA diagnosed according to the 1987 American College of Rheumatology (ACR) criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria.
- Subject did not receive the following drugs, or received the drugs with stable dosage for at least 28 days prior to the baseline (start of treatment) for RA treatment: Non-steroidal anti-inflammatory drugs (NSAIDs; excluding topical formulations), oral morphine or equivalent opioid analgesics (≤ 30 mg/day), acetaminophen, or oral corticosteroids (≤ 10 mg/day in prednisolone equivalent).
- Subject has active RA as evidenced by both of the following:
- ≥ 6 tender/painful joints (using 68-joint assessment)
- ≥ 6 swollen joints (using 66-joint assessment)
- Subject has CRP \> 0.50 mg/dL. The re-test of CRP will be allowed, if the subject's CRP value at the time of screening test is more than 0.30 mg/dL and also his/her most recent CRP value which was carried out up to 90 days before the date of screening test was more than 0.5 mg/dL.
- Subject meets the ACR 1991 Revised Criteria for the Classification of Global Functional Status in RA Class I, II, or III.
- Subject has inadequate response or intolerance for MTX.
- For inadequate responder to MTX, subject has had regular use of MTX for at least 90 days prior to screening at a dose that, in accordance with local clinical practice, is considered acceptable to adequately assess clinical response. The dose of MTX must have been a stable, unchanging oral dose of 7.5 to 20 mg/week (or the equivalent injectable dose) for at least the 28 days prior to screening. Subject is able to continue stable dose of MTX from at least 28 days prior to screening until the end of the administration period of study drug.
- For subject who is intolerant of MTX, subject has had regular use of the following DMARDs, and when the following DMARDs are concomitantly administered to subject, the drugs must be administered for at least 90 days prior to screening, and must be stable from at least 28 days prior to screening until the end of the administration period of study drug.
- Hydroxychloroquine
- Salazosulfapyridine
- Gold
- D-penicillamine
- +4 more criteria
You may not qualify if:
- Subject has received a biologic DMARD within the specified period:
- Anakinra: within 28 days prior to baseline
- Etanercept: within 28 days prior to baseline
- Adalimumab, infliximab: within 56 days prior to baseline
- Golimumab, certolizumab pegol: within 70 days prior to baseline
- Abatacept, tocilizumab: within 84 days prior to baseline
- Denosumab: within 150 days prior to baseline
- Rituximab: within 180 days prior to baseline
- Subject has inadequate response to at least 3 biologic DMARDs.
- Subject has received a non-biologic DMARD listed below or other drugs used in the treatment of RA within 28 days prior to baseline. Leflunomide is prohibited within 90 days prior to baseline. Alternatively, leflunomide is prohibited at least 28 days prior to baseline if washout with cholestyramine for at least 17 days is completed within 28 days prior to baseline. However, topical drugs other than those for the treatment of RA may be used concomitantly.
- Leflunomide
- Tacrolimus
- Cyclosporine
- Cyclophosphamide
- Azathioprine
- +45 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
Site CN00048
Anhui, China
Site CN00045
Beijing, China
Site CN00054
Beijing, China
Site CN00050
Bengbu, China
Site CN00061
Changchun, China
Site CN00032
Changsha, China
Site CN00076
Chenzhou, China
Site CN00071
Guangdong, China
Site CN00016
Guangzhou, China
Site CN00052
Guangzhou, China
Site CN00063
Guangzhou, China
Site CN00072
Guangzhou, China
Site CN00058
Inner Mongolia, China
Site CN00074
Jieyang, China
Site CN00028
Jilin, China
Site CN00069
Jining, China
Site CN00064
Jiujiang, China
Site CN00046
Kunming, China
Site CN00060
Nanjing, China
Site CN00070
Nanjing, China
Site CN00068
Ningbo, China
Site CN00075
Pingxiang, China
Site CN00066
Qingdao, China
Site CN00056
Shanghai, China
Site CN00047
Shantou, China
Site CN00053
Sichuan, China
Site CN00057
Tianjin, China
Site CN00062
Tianjin, China
Site CN00059
Wuhan, China
Site CN00067
Xining, China
Site CN00065
Xuzhou, China
Site CN00073
Zhengzhou, China
Site CN00049
Zhuzhou, China
Site KR00037
Gwangju, South Korea
Site KR00036
Incheon, South Korea
Site KR00033
Seoul, South Korea
Site KR00034
Seoul, South Korea
Site KR00035
Seoul, South Korea
Site TW00022
Taichung, Taiwan
Site TW00023
Taichung, Taiwan
Site TW00024
Taichung, Taiwan
Site TW00025
Taipei, Taiwan
Site TW00026
Taipei, Taiwan
Related Publications (1)
Yang Y, Li J, Liu J, Liu L, Wang Y, Hu J, Li Z, Gu J, Zhang X, Xiao Z, Zheng J, Liu L, Li Z, Wei JC. Safety and efficacy of peficitinib in Asian patients with rheumatoid arthritis who had an inadequate response or intolerance to methotrexate: results of a multicenter, randomized, double-blind, placebo-controlled phase 3 study. Lancet Reg Health West Pac. 2023 Oct 18;42:100925. doi: 10.1016/j.lanwpc.2023.100925. eCollection 2024 Jan.
PMID: 38357391DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2018
First Posted
September 6, 2018
Study Start
September 27, 2018
Primary Completion
April 1, 2021
Study Completion
November 2, 2021
Last Updated
October 21, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
- Access Criteria
- Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.